SAINT LOUIS: In the midst of a national debate over direct-to-consumer advertising, consumers are urging the Food and Drug Administration (FDA) to exercise the new authority granted to them with the recent passage of the FDA reform bill. The Prescription Drug User Fee Act, signed into law by President Bush in September, gives the FDA the power to levy up to $500,000 in fines against pharmaceutical companies for false and misleading ads.
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The mental health watchdog group, Citizens Commission on Human Rights (CCHR), says that nowhere is this need for regulation more essential than in the deceptive ads for drugs designed to alter mood and behavior. According to CCHR, the “chemical imbalance†theory fed to the public through advertisements in order to rationalize the widespread use of psychiatric drugsâ€â€documented to cause suicide, homicidal ideation, heart attack, stroke and sudden deathâ€â€is a marketing tool and is not based on scientific evidence.
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In his book Blaming the Brain (1998), neuroscientist Elliot Valenstein wrote, “Although it is often stated with great confidence that depressed people have a serotonin or norepinephrine [brain chemicals] deficiency, the evidence actually contradicts these claims.â€Â
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An article in the November issue of the journal Society entitled, “The Media and the Chemical Imbalance Theory of Depression,†reaches a similar conclusion. Authors Jonathan Leo and Jeffrey Lacasse write, “The advertisement takes a correlation between serotonin shortage and psychological stressâ€â€and even this is highly questionable and unverifiable in any individual caseâ€â€and makes a leap of faith to the conclusion that depression is caused by a serotonin imbalance…And the marketing did not stop with depression; eventually we were told that whatever our problems might be, whether anxiety, excessive shyness, depression, or the inability to pay attention, the underlying cause was a faulty transmitter level which could be rectified with a pill.â€Â
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Despite the controversy over advertising directly to consumersâ€â€a practice permitted only in the United States and New Zealandâ€â€spending on these advertisements reached $4.5 billion in 2006. This year, following the passage of stronger drug safety legislation, a crackdown has already begun on the fraudulent marketing of antidepressants. In December, the FDA released a letter to drug manufacturer Wyeth criticizing their ads for the antidepressant Effexor, saying that the ads minimize the risks and overstate the effectiveness of the drug.
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CCHR applauds this move but urges that the FDA do more to regulate the misleading messages. A 2003 Consumers Union analysis of several years of drug ads found “a broad and disconcerting range of misleading messages†including “ads that minimized the product risk†and “exaggerated its efficacyâ€Â. Leo and Lacasse conclude in a 2005 essay in the Public Library of Science Medicine, entitled “Serotonin and Depression: A Disconnect between the Advertisements and the Scientific Literature,†that “The incongruence [disagreement] between the scientific literature and the claims made in FDA-regulated SSRI [Selective Serotonin Reuptake Inhibitor – newer antidepressant] advertisements is remarkable, and possibly unparalleled.â€Â
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CCHR is joining consumers in calling for a ban on fraudulent claims by drug manufacturersâ€â€the most egregious being the fraudulent and unproven claim that depression is due to a “chemical imbalance†and that antidepressants work to correct this imbalance. Psychiatrists themselves admit there are no tests, such as brain scans, x-rays, urine samples or any chemical imbalance tests, which can verify the existence of psychiatric disorders. Click here for more information about the chemical imbalance hoax.
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The Citizens Commission on Human Rights is an international psychiatric watchdog group co-founded in 1969 by the Church of Scientology and Dr. Thomas Szasz, Professor of Psychiatry Emeritus, to investigate and expose psychiatric violations of human rights. Contact CCHR St. Louis at 314-727-8307 or www.CCHRSTL.org.